In this retrospective non-interventional study (NIS), the subjective and objective benefit of patients with retinitis pigmentosa (and other dystrophies like Usher, Choroideremia or cone-rod dystrophy), who have been prescribed the therapy of transcorneal electrostimulation (TcES) with the OkuStim System, is assessed.
The medical device OkuStim received the CE mark (a symbol of free marketability in the European Economic Area) in 2011 and is commercially available for patients in Europe since 2014. Since then, patients with retinitis pigmentosa and other dystrophies have regularly applied the therapy of transcorneal electrostimulation (TcES) with OkuStim. So far, the benefits of the therapy and the experiences of the patients with regular, multi-year use have not been systematically recorded. In this retrospective non-interventional study (NIS) with patients which have been using TcES since \>1 year, data present for visual field, best-corrected visual acuity (BCVA) and central foveal thickness (as assessed via OCT) is collected. In addition, reasons for discontinuation of therapy and patient satisfaction with TcES are assessed via a questionnaire. Side-effects are also recorded, if present in the patient files.
Study Type
OBSERVATIONAL
Enrollment
49
Transcorneal electrostimulation, usually applied once per week for 30 min (home-use).
Universitätsklinikum Heidelberg, Augenklinik
Heidelberg, Germany
Klinikum Stuttgart gKAöR, Augenklinik Standort Mitte (Katharinenhospital)
Stuttgart, Germany
Universitäts-Augenklinik Tübingen, Abt. für Augenheilkunde
Tübingen, Germany
Universitätsspital Basel, Augenklinik
Basel, Switzerland
Visual field
Assessment of changes compared to baseline (before TcES was started)
Time frame: Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy.
Best-corrected visual acuity
Assessment of changes compared to baseline (before TcES was started)
Time frame: Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy.
Central foveal thickness
Assessment of changes compared to baseline (before TcES was started)
Time frame: Baseline and then all data present in patient files after begin of therapy. Depending on how long the patient already uses OkuStim, the time frame varies between 1 year and several years after commencement of therapy.
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